Translating Research Into Practice for Postpartum Depression

Postpartum Depression Clinical Trial

— TRIPPD  

Official title:

Practice Based Clinical Trial of Screening, Diagnosis and Follow up Management for Postpartum Depression in Family Medicine Practices.

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00548743
• Other study ID #: 5R01HS014744-02
• Status: Unknown status
• Phase: N/A
• First received: October 22, 2007
• Last updated: December 3, 2007
• Start date: September 2005
• Est. completion date: August 2010

Study information

• Verified date: October 2007
• Source: Olmsted Medical Center
• Contact: Barbara P Yawn, MD MSc
• Phone: 507 287 2758
• Email: byawn[@]olmmed.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a study to assess the impact of introducing screening and planned follow up for postpartum depression. All women ages 18 to 45 who speak English or Spanish who come to the enrolled community family medicine offices will either be given usual care or screened using the Edinburgh Postnatal Depression Screening tool. If the EDPS score is high the women will be given the PHQ-9 to more clearly identify the specific likelihood of being depressed. Women who are determined to be depressed will be treated with medication or counseling based on the preference of the women and their physicians. Women will be followed through nurse initiated phone calls and visits to the physicians office.

Outcomes include the level of depression symptoms, measure of comfort with parenting, and satisfaction with partner relationships comparing baseline levels with those at 6 and 12 months from the usual care and intervention sites. These data will be collected by questionnaire. In addition, with the women's permission, medical records will be reviewed.

Description:

A randomized controlled trial of screening and management of postpartum depression that includes a second phase assessing the maintenance of the intervention in the original intervention sites and a switch from usual care to intervention in the control sites.

Planned enrollment includes 29 family medicine practices and 3000 women over a period of four years. All follow up and management is initiated within the family medicine practices to improve generalizability and likelihood for dissemination.

In addition to the patient centered outcomes, exploratory analyses will look at the uptake and degree of implementation and maintenance of the intervention based on characteristics of the practice including size, location, affiliation with larger group, type of practice and whether or not the practice is a community health center or residency practice.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 3000
• Est. completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 5 to 12 weeks postpartum

• Able to speak and read English or Spanish

• 18 to 45 years of age

Exclusion Criteria:

• Significant cognitive impairment and unable to answer screening questions

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Behavioral:
• Screening and follow up
Two stage screening with EPDS and PHQ-9, treatment for depression at physician's discretion and follow up phone calls and visits
• Usual care
usual care for identification and management of postpartum depression

Locations

Country	Name	City	State
United States	Olmsted Medical Center	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Olmsted Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of depressive symptoms and level of parenting comfort		12 months postpartum
Secondary	Percent eligible women screened and of those screen positive, percent treated and followed according to protocol		12 months for each women

External Links

•   Describes study for sites not for patients